Buda-Nowak Anna, Kucharz Jakub, Dumnicka Paulina, Kuzniewski Marek, Herman Roman Maria, Zygulska Aneta L, Kusnierz-Cabala Beata
Department of Oncology, University Hospital in Krakow, Sniadeckich 10, 31-531, Cracow, Poland.
Department of Experimental and Clinical Surgery, Jagiellonian University Medical College, Michalowskiego 12, Cracow, 31-126, Poland.
Med Oncol. 2017 Apr;34(4):68. doi: 10.1007/s12032-017-0928-z. Epub 2017 Mar 25.
Sunitinib is a tyrosine kinase inhibitor (TKI) used in treatment of metastatic renal cell carcinoma (mRCC), gastrointestinal stromal tumors and pancreatic neuroendocrine tumors. One of the most common side effects related to sunitinib is hypothyroidism. Recent trials suggest correlation between the incidence of hypothyroidism and treatment outcome in patients treated with TKI. This study evaluates whether development of hypothyroidism is a predictive marker of progression-free survival (PFS) in patients with mRCC treated with sunitinib. Twenty-seven patients diagnosed with clear cell mRCC, after nephrectomy and in 'good' or 'intermediate' MSKCC risk prognostic group, were included in the study. All patients received sunitinib as a first-line treatment on a standard schedule (initial dose 50 mg/day, 4 weeks on, 2 weeks off). The thyroid-stimulating hormone serum levels were obtained at the baseline and every 12 weeks of treatment. In statistic analyses, we used Kaplan-Meier method for assessment of progression-free survival; for comparison of survival, we used log-rank test. In our study, the incidence of hypothyroidism was 44%. The patients who had developed hypothyroidism had better median PFS to patients with normal thyroid function 28,3 months [95% (CI) 20.4-36.2 months] versus 9.8 months (6.4-13.1 months). In survival analysis, we perceive that thyroid dysfunction is a predictive factor of a progression-free survival (PFS). In the unified group of patients, the development of hypothyroidism during treatment with sunitinib is a positive marker for PFS. During that treatment, thyroid function should be evaluated regularly.
舒尼替尼是一种酪氨酸激酶抑制剂（TKI），用于治疗转移性肾细胞癌（mRCC）、胃肠道间质瘤和胰腺神经内分泌肿瘤。与舒尼替尼相关的最常见副作用之一是甲状腺功能减退。最近的试验表明，TKI治疗患者的甲状腺功能减退发生率与治疗结果之间存在相关性。本研究评估甲状腺功能减退的发生是否是接受舒尼替尼治疗的mRCC患者无进展生存期（PFS）的预测标志物。本研究纳入了27例诊断为透明细胞mRCC的患者，这些患者在肾切除术后处于MSKCC风险预后“良好”或“中等”组。所有患者均按照标准方案接受舒尼替尼一线治疗（初始剂量50mg/天，服用4周，停药2周）。在基线和治疗的每12周测定促甲状腺激素血清水平。在统计分析中，我们使用Kaplan-Meier方法评估无进展生存期；为比较生存率，我们使用对数秩检验。在我们的研究中，甲状腺功能减退的发生率为44%。发生甲状腺功能减退的患者的中位PFS优于甲状腺功能正常的患者，分别为28.3个月[95%（CI）20.4 - 36.2个月]和9.8个月（6.4 - 13.1个月）。在生存分析中，我们认为甲状腺功能障碍是无进展生存期（PFS）的预测因素。在统一的患者组中，舒尼替尼治疗期间甲状腺功能减退的发生是PFS的阳性标志物。在该治疗期间，应定期评估甲状腺功能。
